First-Time Generic Approvals: Klaron, MetroGel-Vaginal, Colestid

Yael Waknine

November 21, 2006

November 21, 2006 — The US Food and Drug Administration (FDA) has approved first-time generic formulations for sulfacetamide sodium 10% topical solution in the treatment of acne; metronidazole 0.75% vaginal gel for the treatment of bacterial vaginosis; and colestipol HCl 1-g tablets for the treatment of hypercholesterolemia that is refractory to dietary changes alone.

Generic Sulfacetamide Sodium 10% Topical Solution (Klaron) for Acne

On November 17, the FDA approved a first-time generic formulation for sulfacetamide sodium 10% topical solution (made by Fougera, a division of Altana, Inc; brand name Klaron, made by Dermik Laboratories, Inc).

According to a company news release, the product began shipping immediately and will be available in 118-mL (4-oz) bottles.

Sulfacetamide 10% topical solution is indicated for the twice-daily treatment of acne vulgaris.

Generic 0.75% Metronidazole Vaginal Gel (MetroGel-Vaginal) for Bacterial Vaginosis

On October 31, the FDA approved a first-time generic formulation for metronidazole 0.75% vaginal gel (made by QLT USA, Inc; brand name MetroGel-Vaginal, made by 3M Pharmaceuticals).

Metronidazole 0.75% vaginal gel is indicated for the 5-day treatment of bacterial vaginosis (formerly referred to as Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, Corynebacterium vaginitis, or anaerobic vaginosis).

The FDA notes that other pathogens commonly associated with vulvovaginitis should be ruled out, including Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, Candida albicans , and herpes simplex virus.

Generic Colestipol Tablets (Colestid) for Adjunctive Treatment of Hypercholesterolemia

On October 31, the FDA approved a first-time generic formulation for colestipol HCl 1-g tablets (made by Impax Laboratories, Inc; brand name Colestid, made by Pfizer, Inc).

Colestipol tablets and oral suspension are indicated as an adjunctive therapy to diet for the reduction of elevated serum total and low-density lipoprotein cholesterol in patients with primary hypercholesterolemia who do not respond adequately to dietary changes.

Generic formulations for the 5-g packet and scoopful for oral suspension (also made by Impax Labs) were previously approved by the FDA in May 2005.


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